Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000865910
Ethics application status
Approved
Date submitted
8/08/2011
Date registered
15/08/2011
Date last updated
17/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase III Randomised, Double-blind, Placebo-controlled Trial to Assess the Efficacy of Tranexamic Acid in Reducing the Blood Loss in Patients with Per-rectal Bleeding
Scientific title
A Phase III Randomised, Double-blind, Placebo-controlled Pragmatic Trial to Assess the Efficacy of Tranexamic Acid in Reducing the Blood Loss in Patients with Per-rectal Bleeding
Secondary ID [1] 262741 0
Clinical Trial Procotol Number JHHGIS01
Universal Trial Number (UTN)
Trial acronym
TRAPR Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lower gastrointestinal bleeding 270450 0
Condition category
Condition code
Oral and Gastrointestinal 270598 270598 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tranexamic acid 1000mg taken orally every 6 hours for 4 days.
Intervention code [1] 267088 0
Treatment: Drugs
Comparator / control treatment
Placebo capsule, consisting of rice flour-based capsule, taken orally every 6 hours for four days.
Control group
Placebo

Outcomes
Primary outcome [1] 269337 0
Blood loss as assessed by reduction in haemoglobin concentration.
Timepoint [1] 269337 0
Day 1, 2, 3, 4 and day of discharge
Secondary outcome [1] 279407 0
Number of units of packed red blood cells administered to participants according to the clinical record
Timepoint [1] 279407 0
At time of discharge

Eligibility
Key inclusion criteria
Written informed consent
Per rectum bleeding
Able to swallow study medications
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects less than 18 years
Patients with dementia or other health conditions that prevent a person from giving written informed consent.
History of thromboembolic disease or family history of same.
Subjects taking warfarin.
Subjects that are within 12 months of insertion of a drug-eluting stent.
Subjects that are within 12 weeks of placement of a bare metal stent.
Subjects that are pregnant and/or breastfeeding.
Subjects with a known gastrointestinal malignancy
Subjects with a known cancer in the palliative care phase of their treatment.
Subjects with a known allergy to tranexamic acid or its excipients.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After a potential partiticipant has met all eligibility criteria and written informed consent has been obtained, the researcher will randomise the patient by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/11/2011
Actual
9/11/2011
Date of last participant enrolment
Anticipated
Actual
7/01/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1194 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 7056 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 267558 0
Hospital
Name [1] 267558 0
John Hunter Hospital
Country [1] 267558 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Lookout Road
New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 266594 0
None
Name [1] 266594 0
Address [1] 266594 0
Country [1] 266594 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269522 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 269522 0
Ethics committee country [1] 269522 0
Australia
Date submitted for ethics approval [1] 269522 0
Approval date [1] 269522 0
01/08/2011
Ethics approval number [1] 269522 0
11/07/20/3.06

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32954 0
Dr Stephen Smith
Address 32954 0
Division of Surgery
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 32954 0
Australia
Phone 32954 0
+61 2 49855568
Fax 32954 0
Email 32954 0
stephen.smith@hnehealth.nsw.gov.au
Contact person for public queries
Name 16201 0
Rosemary Carroll
Address 16201 0
Division of Surgery
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 16201 0
Australia
Phone 16201 0
+61 2 49855153
Fax 16201 0
+61 2 49214274
Email 16201 0
rosemary.carroll@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 7129 0
Dr Stephen Smith
Address 7129 0
Division of Surgery
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 7129 0
Australia
Phone 7129 0
+61 2 49855153
Fax 7129 0
Email 7129 0
stephen.smith@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTranexamic Acid for Lower GI Hemorrhage: A Randomized Placebo-Controlled Clinical Trial.2018https://dx.doi.org/10.1097/DCR.0000000000000943
N.B. These documents automatically identified may not have been verified by the study sponsor.